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2.
J Plast Reconstr Aesthet Surg ; 75(11): 4202-4211, 2022 11.
Article in English | MEDLINE | ID: mdl-36210292

ABSTRACT

BACKGROUND: Peripheral vascular malformations (VMs) may lead to disfigurement of the body and face, potentially impairing aesthetic appearance. Yet, data on appearance in this population is limited. This study aimed to examine appearance-related concerns and their impact on health-related quality of life (HR-QoL) in patients with VMs. METHODS: In this cross-sectional study, 384 adults and 194 children with VMs were invited to complete the Outcome Measures for VAscular MAlformations (OVAMA) questionnaire to evaluate potential appearance-related concerns on a five-point verbal-rating scale, with higher scores indicating more appearance-related concerns (e.g., colour-difference, facial-distortion, reduced self-esteem, and dissatisfaction with appearance). HR-QoL was evaluated using Patient-Reported Outcome Measurement Information System (PROMIS). Subgroups of patients reporting more appearance-related concerns were identified using univariate analysis. Associations between appearance-related concerns and various HR-QoL domains (e.g., anxiety and social participation) were assessed. RESULTS: A total of 184 patients (32%) completed the questionnaires; 121 patients (66%) reported that one or more appearance outcome was severely affected (i.e., 4-5 out of 5). The following factors statistically significant associated with more appearance-related concerns: capillary/combined origin, facial localization, subcutaneous tissue involvement, larger size, overgrowth, and diagnosis of a syndrome. In adults, dissatisfaction with appearance and reduced self-esteem due to the appearance of the VM correlated with more anxiety and depression symptoms. Reduced self-esteem correlated with less social participation. In children, bodily distortion and being stared at were correlated with less peer relationships. CONCLUSION: Severe appearance-related concerns were present in two-thirds of patients with VMs, impairing their mental HR-QoL. Clinicians should acknowledge appearance-related aspects, monitor psychological well-being, and offer intervention aimed at improving satisfaction with appearance.


Subject(s)
Quality of Life , Vascular Malformations , Adult , Child , Humans , Quality of Life/psychology , Cross-Sectional Studies , Self Concept , Surveys and Questionnaires
4.
Cardiovasc Intervent Radiol ; 41(10): 1494-1504, 2018 Oct.
Article in English | MEDLINE | ID: mdl-29948003

ABSTRACT

PURPOSE: There is paucity of data on patient-perceived outcomes of bleomycin sclerotherapy for low-flow vascular malformations. In this study, the long-term outcomes of bleomycin sclerotherapy were investigated in terms of quality of life (QoL) and patient-perceived changes in health. MATERIALS AND METHODS: A cohort of Dutch patients with vascular malformations treated with bleomycin sclerotherapy (June 2010-November 2015) completed a questionnaire evaluating disease symptoms, QoL (Short Form 36), patient-perceived change in health status (Global Rating of Change scales) and treatment satisfaction. QoL was assessed for the patient's status before and after treatment and was analyzed relative to an age and sex-matched Dutch reference population. Predictive factors associated with QoL and patient-perceived improvement in overall health status were assessed using multivariable linear and logistic regression analyses, respectively. RESULTS: Seventy-seven patients, with a median follow-up of 22 months, were enrolled. About half of the respondents (49.3%) indicated that they perceived (any form of) improvement in their overall health status. Most often improved were the specific health aspects 'pain' (54.5%) and 'overall severity of symptoms' (57.1%). No factors were significantly predictive for patient-perceived improvement in health with respect to the vascular malformation. Impairment in work- or study-related activities prior to sclerotherapy was found to negatively impact physical QoL at follow-up (p = 0.03). CONCLUSION: Approximately half of patients with low-flow vascular malformations indicate an improvement in overall health status following bleomycin sclerotherapy, particularly concerning pain and severity of symptoms. However, most patients only perceived little to moderate improvement to their health and desire further treatment.


Subject(s)
Bleomycin/administration & dosage , Lymphatic Abnormalities/therapy , Patient Satisfaction , Quality of Life/psychology , Sclerotherapy/methods , Vascular Malformations/therapy , Adult , Cohort Studies , Female , Follow-Up Studies , Humans , Lymphatic Abnormalities/psychology , Male , Middle Aged , Netherlands , Prognosis , Retrospective Studies , Sclerotherapy/psychology , Surveys and Questionnaires , Treatment Outcome , Vascular Malformations/psychology
5.
Br J Dermatol ; 176(6): 1465-1474, 2017 Jun.
Article in English | MEDLINE | ID: mdl-27797396

ABSTRACT

BACKGROUND: There is a lack of evidence for minocycline in the treatment of rosacea. OBJECTIVES: To compare the efficacy and safety of doxycycline 40 mg vs. minocycline 100 mg in papulopustular rosacea. METHODS: In this randomized, single-centre, 1 : 1 allocation, assessor-blinded, noninferiority trial, patients with mild-to-severe papulopustular rosacea were randomly allocated to either oral doxycycline 40 mg or minocycline 100 mg for a 16-week period with 12 weeks of follow-up. Our primary outcomes were the change in lesion count and change in patient's health-related quality of life (using RosaQoL). Intention-to-treat and per protocol analyses were performed. RESULTS: Of the 80 patients randomized (40 minocycline, 40 doxycycline), 71 were treated for 16 weeks. Sixty-eight patients completed the study. At week 16, the median change in lesion count was comparable in both groups: doxycycline vs. minocycline, respectively 13 vs. 14 fewer lesions. The RosaQoL scores were decreased for both doxycycline and minocycline, respectively by 0·62 and 0·86. Secondary outcomes were comparable except for Investigator's Global Assessment success, which was seen significantly more often in the minocycline group than in the doxycycline group (60% vs. 18%, P < 0·001). At week 28, outcomes were comparable, except for RosaQoL scores and PaGA, which were significantly different in favour of minocycline (P = 0·005 and P = 0·043, respectively), and fewer relapses were recorded in the minocycline group than in the doxycycline group (7% and 48%, respectively; P < 0·001). No serious adverse reactions were reported. CONCLUSIONS: Minocycline 100 mg is noninferior to doxycycline 40 mg in efficacy over a 16- week treatment period. At follow-up, RosaQoL and PaGA were statistically significantly more improved in the minocycline group than in the doxycycline group, and minocycline 100 mg gives longer remission. In this study there was no significant difference in safety between these treatments; however, based on previous literature minocycline has a lower risk-to-benefit ratio than doxycycline. Minocycline 100 mg may be a good alternative treatment for those patients who, for any reason, are unable or unwilling to take doxycycline 40 mg.


Subject(s)
Anti-Bacterial Agents/administration & dosage , Dermatologic Agents/administration & dosage , Doxycycline/administration & dosage , Facial Dermatoses/drug therapy , Minocycline/administration & dosage , Rosacea/drug therapy , Administration, Oral , Anti-Bacterial Agents/adverse effects , Dermatologic Agents/adverse effects , Doxycycline/adverse effects , Drug Administration Schedule , Female , Humans , Male , Minocycline/adverse effects , Quality of Life , Recurrence , Single-Blind Method , Treatment Outcome
6.
Br J Dermatol ; 176(3): 624-633, 2017 Mar.
Article in English | MEDLINE | ID: mdl-27416891

ABSTRACT

BACKGROUND: There are currently no independent data available comparing infliximab and etanercept for the treatment of psoriasis. OBJECTIVES: To compare these biologics without funding from pharmaceutical companies. METHODS: Overall, 50 patients were randomized to etanercept (n = 23) 50 mg subcutaneously twice weekly or infliximab (n = 25) 5 mg kg-1 intravenously at week 0, 2, 6, 14 and 22. After 24 weeks, 19 patients stopped and 22 continued treatment and were followed up to week 48. The primary outcome was ≥ 75% improvement of Psoriasis Area and Severity Index (PASI 75) at week 24. The secondary outcomes included PASI 75 at week 6 (onset of action) and week 12, Investigator's Global Assessment (IGA), Patient Global Assessment, impact on quality of life (Skindex-17 and SF-36), Treatment Satisfaction Questionnaire of Medication, duration of remission, maintenance treatment and safety. RESULTS: At week 24, PASI 75 was achieved in 72% (infliximab) vs. 35% (etanercept) (P = 0·01). The onset of action was achieved in 52% (infliximab) and 4% (etanercept). At week 12, 76% (infliximab) and 22% (etanercept) achieved PASI 75 (P < 0·001). At week 24, IGA 'clear or almost clear' was observed in 76% (infliximab) and 30% (etanercept) (P = 0·01). Skindex-17 symptom score was significantly better for infliximab. Maintenance treatment achieved PASI 75 for 67% (n = 6) infliximab vs. 50% (n = 5) etanercept, at week 48 (P = 0·65). Mild adverse events were reported in 76% (infliximab) vs. 66% (etanercept). CONCLUSIONS: Infliximab showed a rapid and significant higher level of efficacy until week 24 compared with etanercept. Long-term data showed no significant differences between both groups at week 48. Safety parameters were comparable.


Subject(s)
Dermatologic Agents/administration & dosage , Etanercept/administration & dosage , Infliximab/administration & dosage , Psoriasis/drug therapy , Adolescent , Adult , Aged , Chronic Disease , Drug Administration Schedule , Etanercept/adverse effects , Female , Humans , Infliximab/adverse effects , Injections, Subcutaneous , Male , Middle Aged , Patient Satisfaction , Prospective Studies , Quality of Life , Single-Blind Method , Treatment Outcome , Young Adult
8.
Br J Dermatol ; 172(1): 8-10, 2015 Jan.
Article in English | MEDLINE | ID: mdl-25581584

ABSTRACT

AIM: Arits et al. aimed to assess whether the effectiveness of imiquimod and fluorouracil is not inferior to methyl aminolaevulinic acid (MAL) photodynamic therapy (PDT) in patients with superficial basal cell carcinoma. SETTING AND DESIGN: This single-blind, noninferiority, randomized controlled trial was conducted at one coordinating academic hospital and six peripheral dermatological departments in the Netherlands between March 2008 and August 2010. STUDY EXPOSURE: Patients with a superficial basal cell carcinoma were randomly assigned to be treated with PDT (two treatments); or imiquimod 5% cream, once daily five times a week for 6 weeks; or fluorouracil 5% cream twice daily for 4 weeks. Follow-up visits were planned after 3 months and 1 year. OUTCOMES: The primary outcome was defined as the probability that a patient was free of tumour reoccurrence at both 3 and 12 months' follow-up. Secondary outcomes were aesthetic outcome of the treated area, compliance and adverse reactions. RESULTS: In total 911 patients were assessed for eligibility, of whom 601 were randomized: 202 to receive MAL-PDT, 198 to receive imiquimod cream and 201 to receive fluorouracil cream. The proportions (95% confidence intervals) of patients tumour free at both 3 and 12 months were 72·8% (66·8-79·4) for MAL-PDT, 83·4% (78·2-88·9) for imiquimod cream and 80·1% (74·7-85·9) for fluorouracil cream. For patients treated with MAL-PDT, moderate-to-severe pain and burning sensation were reported most often during the treatment itself. For the creams, moderate-to-severe local swelling, erosion, crust formation and itching of the skin were mentioned most often. CONCLUSIONS: Arits et al. conclude that topical fluorouracil was noninferior and imiquimod was superior to MAL-PDT for treatment of superficial basal cell carcinoma. Imiquimod cream is suggested as the preferred treatment.


Subject(s)
Aminolevulinic Acid/therapeutic use , Aminoquinolines/administration & dosage , Carcinoma, Basal Cell/drug therapy , Fluorouracil/administration & dosage , Photochemotherapy , Photosensitizing Agents/therapeutic use , Skin Neoplasms/drug therapy , Female , Humans , Male
9.
J Eur Acad Dermatol Venereol ; 29(8): 1636-40, 2015 Aug.
Article in English | MEDLINE | ID: mdl-25175822

ABSTRACT

BACKGROUND: Clinical practice guideline (CPG) development starts with selecting appropriate topics, as resources to develop a guideline are limited. However, a standardized method for topic selection is commonly missing and the way different criteria are used to prioritize is not clear. OBJECTIVES: To select and prioritize dermatological topics for CPG development and elucidate criteria dermatologists find important in selecting guideline topics. METHODS: All 410 dermatologists in the Netherlands were asked to create a top 20 of dermatological topics for which a guideline would be desirable, regardless of existing guidelines. They also rated, on a 5-point Likert scale, 10 determinative criteria derived from a combined search in literature and across (inter)national guideline developers. Top 20 topics received scores ranging from 0.01 to 0.2 and combined scores yielded a total score. RESULTS: The 118 surveys (response 29%) identified 157 different topics. Melanoma, squamous cell carcinoma, basal cell carcinoma, psoriasis and atopic dermatitis are top priority guideline topics. Venous leg ulcer, vasculitis, varicose veins, urticaria, acne, Lyme borreliosis, cutaneous lupus erythematosus, pruritus, syphilis, lymphoedema, decubitus ulcer, hidradenitis suppurativa, androgenic alopecia and bullous pemphigoïd complete the top 20. A further 15 topics have overlapping confidence intervals. Mortality and healthcare costs are regarded as less important criteria in topic selection (P < 0.04), than other criteria like the potential to reduce unwanted variation in practice. CONCLUSION: Dermatological professional organizations worldwide succeeded in developing guidelines for all top 20 topics. Respondents mostly agree with (inter)national guideline programmes and literature concerning the criteria important to selecting guideline topics.


Subject(s)
Dermatology , Practice Guidelines as Topic , Skin Diseases , Humans , Netherlands , Research , Skin Diseases/classification
10.
Br J Dermatol ; 172(4): 1008-13, 2015 Apr.
Article in English | MEDLINE | ID: mdl-25123410

ABSTRACT

BACKGROUND: Clinical practice guideline implementation may be at variance with actual daily practice, as guideline adherence is a complex process depending on many actors and factors. Feedback regarding adherence is essential to monitor the effect that a guideline has in clinical practice and whether or not the quality of care is raised by implementation. OBJECTIVES: Developing a tool for obtaining and giving nationwide feedback regarding adherence. METHODS: From February 2010 to June 2013, a 32-item questionnaire was used as an audit tool during committee visits to assess adherence across 37 dermatological centres in The Netherlands. The questions were derived from the recommendations by the Dutch Dermatological and Venereological Society (NVDV) in the Dutch Basal Cell Carcinoma (BCC) guideline. Five selected medical records per dermatologist were audited and the results were discussed with the audited centre. Data were pooled to calculate the compliance with each recommendation across all participating centres. RESULTS: Adherence to recommended actions varied considerably (20·2-100%) across the domains of prevention, diagnostics, treatments and aftercare. Using and reporting surgical margins, giving patient advice, restricting the use of cryosurgery for certain BCCs and reporting on prognostic factors all failed to reach a threshold of 80%. Nonadherence to recommended actions proved to be related to whether or not a dermatologist was directly involved. CONCLUSIONS: The findings emphasize the importance of direct feedback to practitioners regarding adherence. Furthermore, together with existing frameworks, the method described could be used by developers in a guideline update to identify and anticipate barriers to successful implementation.


Subject(s)
Carcinoma, Basal Cell/therapy , Guideline Adherence , Practice Guidelines as Topic , Skin Neoplasms/therapy , Female , Humans , Male , Netherlands
11.
Dermatol Online J ; 20(3)2014 Mar 17.
Article in English | MEDLINE | ID: mdl-24656281

ABSTRACT

This document provides a summary of the Dutch S3-guidelines on the treatment of psoriasis. These guidelines were finalized in December 2011 and contain unique chapters on the treatment of psoriasis of the face and flexures, childhood psoriasis as well as the patient's perspective on treatment. They also cover the topical treatment of psoriasis, photo(chemo)therapy, conventional systemic therapy and biological therapy.


Subject(s)
Psoriasis/therapy , Adult , Anti-Inflammatory Agents/therapeutic use , Antibodies, Monoclonal/therapeutic use , Biological Products/therapeutic use , Child , Combined Modality Therapy , Contraindications , Drug Administration Routes , Drug Administration Schedule , Drug Interactions , Drug Therapy, Combination , Humans , Immunosuppressive Agents/therapeutic use , Netherlands , Patient Acceptance of Health Care , Psoriasis/drug therapy , Psoriasis/radiotherapy , Retinoids/therapeutic use , Ultraviolet Therapy/adverse effects , Ultraviolet Therapy/economics
12.
Br J Dermatol ; 171(4): 875-83, 2014 Oct.
Article in English | MEDLINE | ID: mdl-24673245

ABSTRACT

BACKGROUND: Drug survival depends on several factors such as dosing, effectiveness, quality-of-life improvement and safety, and could be seen as an overall marker for treatment success. Such data for biologics in psoriasis treatment are sparse. OBJECTIVES: To determine differences in drug survival between different biologics for psoriasis. METHODS: Drug survival, dosing, Psoriasis Area and Severity Index (PASI) and Skindex-29 at weeks 12 and 52, and adverse events of patients with psoriasis treated with a biologic registered in the local database of the Academic Medical Center, Amsterdam, were analysed. Patients were divided into those naive or non-naive for treatment episodes with biologics. RESULTS: Drug survival did not differ significantly for naive treatment episodes between the biologics (etanercept 85% to 64%, adalimumab 77% to 77%, infliximab 75% to 75% for year 1-4), or for non-naive treatment episodes (etanercept 86% to 42%, adalimumab 84% to 56%, infliximab 68% to 43% for year 1-4; ustekinumab 84% to 57% for year 1-3). The naive group showed better drug survival and PASI 75 response at week 12, although the difference was not significant. A similar improvement of mean ∆PASI and mean ∆Skindex-29 was observed at weeks 12 and 52 for all biologics for both groups, although no significant difference was seen between groups. Treatment termination was due mainly to nonresponse for all biologics. CONCLUSIONS: There was no significant difference in drug survival, mean ∆PASI or Skindex-29 response at weeks 12 or 52 between the biologics or between the naive and non-naive groups. Treatment termination was due mostly to nonresponse. Sequential treatment with the available biologics can be effective.


Subject(s)
Biological Factors/administration & dosage , Psoriasis/drug therapy , Adalimumab , Adult , Antibodies, Monoclonal/administration & dosage , Antibodies, Monoclonal, Humanized/administration & dosage , Drug Administration Schedule , Drug Substitution , Female , Humans , Infliximab , Male , Middle Aged , Prospective Studies , Quality of Life , Severity of Illness Index , Treatment Outcome , Ustekinumab
13.
Br J Dermatol ; 170(3): 501-13, 2014 Mar.
Article in English | MEDLINE | ID: mdl-24116934

ABSTRACT

BACKGROUND: Photo(chemo)therapy is a common treatment modality in patients with atopic dermatitis (AD), but evidence on its effectiveness has not been recently systematically reviewed. OBJECTIVES: To evaluate the effect of treatment with photo(chemo)therapy in patients with AD and to make treatment recommendations on basis of the evidence. METHODS: We performed an electronic literature search in MEDLINE (OVID), EMBASE (OVID), the Cochrane Central Register of Controlled Trials (CENTRAL), Global Resource of EczemA Trials (GREAT) and prospective trial registers, complemented with a search of PubMed to find recent studies not yet available in OVID MEDLINE. All randomized controlled trials (RCTs) on phototherapy for the treatment of AD were considered for data extraction. RESULTS: Nineteen studies were included (905 participants). The identified RCTs were generally clinically and qualitatively heterogeneous. Therefore a formal meta-analysis was not feasible. Conclusions must be drawn carefully because of small sample sizes, varying study quality and sometimes the absence of direct comparisons, but on the basis of the included evidence, ultraviolet (UV) A1 and narrowband (NB)-UVB appeared the most effective treatment modalities for the reduction of clinical signs and symptoms. No difference between high-dose UVA1 and medium-dose UVA1 was seen. UVAB was shown to be more effective than UVA and broadband-UVB for the improvement of clinical symptoms, but not compared with UVA1. Other effective treatment options include full-spectrum light, psoralen plus UVA and balneophototherapy. No serious side-effects were reported. CONCLUSIONS: Phototherapy can be a valid therapeutic option for patients with AD. Based on the results of this review, preference is given to UVA1 and NB-UVB. Further well-designed, adequately powered RCTs are required.


Subject(s)
Dermatitis, Atopic/drug therapy , Photochemotherapy/methods , Adolescent , Adult , Aged , Aged, 80 and over , Child , Dermatitis, Atopic/radiotherapy , Humans , Middle Aged , Randomized Controlled Trials as Topic , Treatment Outcome , Ultraviolet Therapy/methods , Young Adult
14.
Br J Dermatol ; 167(4): 710-3; discussion 714-5, 2012 Oct.
Article in English | MEDLINE | ID: mdl-23013312

ABSTRACT

AIM: Papp et al. (N Engl J Med 2012; 366: 1181-9) and Leonardi et al. (N Engl J Med 2012; 366: 1190-9) respectively assessed the efficacy and safety of brodalumab (AMG 827), a human monoclonal antibody directed against interleukin (IL)-17RA, the receptor of IL-17A and ixekizumab (LY2439821), a humanized anti-IL-17 monoclonal antibody for the treatment of moderate-to-severe plaque psoriasis. SETTING AND DESIGN: In these phase II, multicentre, randomized, double-blind, placebo-controlled, dose-ranging studies, 198 patients with severe chronic plaque-type psoriasis [Psoriasis Area and Severity Index (PASI) ≥ 12, body surface area (BSA) ≥ 10] were enrolled in Papp et al. between December 2009 and April 2010 and 142 patients in Leonardi et al. between April 2010 and March 2011. STUDY EXPOSURE: In Papp et al., patients with chronic plaque-type psoriasis were randomly assigned to receive placebo or brodalumab at a dose of 70, 140 or 210 mg, administered subcutaneously on day 1 and at weeks 1, 2, 4, 6, 8 and 10, or at a dose of 280 mg administered subcutaneously on day 1 and at weeks 4 and 8. In Leonardi et al., patients were randomly assigned to receive subcutaneous injections of placebo or 10, 25, 75 or 150 mg of ixekizumab at 0, 2, 4, 8, 12 and 16 weeks, followed by a 4-week follow-up period. OUTCOMES: In both studies the PASI, static Physician's Global Assessment (sPGA), Dermatology Life Quality Index (DLQI), adverse events, and routine haematological and laboratory values were analysed. Additionally in Papp et al. the BSA and Medical Outcomes Study 36-item short-form health survey, and in Leonardi et al. the joint pain visual analogue scale (VAS), itch severity VAS, Nail Psoriasis Severity Index (NAPSI) and the Psoriasis Scalp Severity Index (PSSI) were also measured. PRIMARY OUTCOME MEASURES: At week 12, in Papp et al. and Leonardi et al.: (A) The percentage improvement in PASI. In Leonardi et al. (and in Papp et al. as one of the secondary outcomes): (B) The percentage of patients who achieved a reduction in the PASI by at least 75% (PASI 75) over baseline. RESULTS: Primary endpoints: (A) At week 12 in Papp et al., the mean improvements in PASI were significantly greater in the 140, 210 and 280 mg brodalumab groups than in the 70 mg brodalumab group (85.9%, 86.3% and 76.0%, respectively, vs. 45.0%; P < 0.001); in addition, the mean improvement in PASI was significantly greater in each brodalumab group than in the placebo group (16.0%; P < 0.001). (At week 16 lower but still significant percentages compared with placebo were seen). In Leonardi et al., the mean improvements in PASI of the 10, 25, 75 and 150 mg ixekizumab groups are not reported. Significant differences between the two highest dose groups and the placebo group were seen as early as 1 week in PASI. (B) At week 12 in Papp et al., the percentages of patients with PASI 75 were 33% in the 70 mg, 77% in the 140 mg, 82% in the 210 mg and 67% in the 280 mg brodalumab group. The percentages of patients with a 50%, 75%, 90% or 100% improvement in PASI at week 12 were significantly higher among patients who received brodalumab (taking into account all doses) than among patients who received placebo. The authors do not give an explanation for the lower improvements at week 16. In Leonardi et al., the PASI 75 occurred in significantly more patients in the 25 mg (76.7%), 75 mg (82.8%) and 150 mg (82.1%) ixekizumab groups vs. placebo (7.7%; P < 0.001). No significant difference was seen for the 10 mg group. Significant differences between the 150 mg group and the placebo group were seen as early as 2 weeks in PASI 75. Differences were sustained through 20 weeks for all clinical measures in the ixekizumab study. Secondary endpoints: At week 12, in Papp et al., significant decreases of BSA, sPGA and DLQI were also seen. In Leonardi et al., significantly higher percentages of patients in the three highest ixekizumab dose groups had an sPGA score of 0 (clear of disease) or of 0 or 1 (minimal disease) for each dose and score group vs. placebo (P < 0.05). Significant reductions in the mean ± SD DLQI scores were detected at 8 weeks in the 150 mg ixekizumab group (-7.8 ± 5.7), the 75 mg ixekizumab group (-8.5 ± 5.1) and the 25 mg ixekizumab group (-7.1 ± 6.5) as compared with placebo (-2.4 ± 4.4) for all comparisons (P < 0.001). In addition, at 16 weeks, significantly more patients had a DLQI score of 0 in the 150, 75 and 25 mg ixekizumab groups (39.3%, 37.9% and 31.0%, respectively) as compared with placebo (0%) for all comparisons (P < 0.05). In Leonardi et al., significant reductions were seen in the PSSI, in the NAPSI and in the itch severity (VAS scores). Significant reductions from baseline of the joint pain VAS were also observed in the 150 mg ixekizumab group at 12 weeks, and this reduction was sustained through 20 weeks. At week 16: with respect to the other secondary efficacy endpoints and patient-reported outcomes, significant improvements in scores were seen compared with placebo, but some of these differences were lower than observed at week 12. SAFETY: Papp et al. summarized that during the first 12 weeks of the trial, 68% of the patients in the 70 mg brodalumab group, 69% (140 mg), 82% (210 mg), 73% (280 mg) and 62% in the placebo group had at least one adverse event. Although the authors mentioned only three serious adverse events, four were reported during the study: renal colic (70 mg brodalumab group), two patients with grade 3 asymptomatic neutropenia (210 mg brodalumab group; Papp et al. clarified that only one of these episodes was a serious adverse event) and an ectopic pregnancy in one patient in the placebo group. Leonardi et al. reported that there were no serious adverse events in any group. The frequency of adverse events was similar between the combined ixekizumab groups and the placebo group. A few patients were withdrawn from the trial due to adverse events including hypertriglyceridaemia (placebo group), peripheral oedema (10 mg ixekizumab), hypersensitivity (10 mg ixekizumab) and urticaria (25 mg ixekizumab). CONCLUSIONS: Papp et al. and Leonardi et al. concluded that brodalumab and ixekizumab, respectively, significantly improved plaque psoriasis in 12-week, phase II studies. For difficult-to-treat areas such as the scalp and nails, significant differences from placebo were observed with ixekizumab treatment. These trials were not large enough or of long enough duration to ascertain uncommon adverse events or to assess the risk of infection or cardiovascular events.

15.
Dermatol Clin ; 30(2): 323-32, x, 2012 Apr.
Article in English | MEDLINE | ID: mdl-22284146

ABSTRACT

Health-related quality of life (HRQoL) is gradually becoming a standard outcome in clinical research and health care management. Nevertheless, application in dermatologic practice is not customary and many practical and attitudinal barriers need to be overcome. To contribute to the discussion on and the implementation of HRQoL assessment in routine dermatologic practice, this article describes (1) why HRQoL assessment is relevant for dermatologic practice, (2) which patients would benefit most from routine HRQoL assessment, and (3) how HRQoL assessment can be applied in clinical practice.


Subject(s)
Health Status , Practice Patterns, Physicians' , Quality of Life , Skin Diseases/psychology , Dermatology , Humans , Surveys and Questionnaires , Treatment Outcome
16.
Allergy ; 67(1): 99-106, 2012 Jan.
Article in English | MEDLINE | ID: mdl-21951293

ABSTRACT

BACKGROUND: Demonstration of adequate reliability and validity is sufficient for concluding that an instrument is applicable for descriptive and predictive purposes, but before we can confidently use an outcome measure in clinical trials, the responsiveness (synonymous with sensitivity to change) and minimal clinically important difference (MCID) should be known. With this study, we aimed to assess responsiveness and MCID of four outcome measures used in atopic eczema: the Severity Scoring of Atopic Dermatitis (SCORAD), the objective SCORAD, Eczema Area and Severity Index (EASI), and the Patient-Oriented Eczema Measure (POEM). METHODS: Data of three randomized controlled trials were used. To demonstrate responsiveness, we plotted receiver operating characteristic (ROC) curves. MCID was estimated using mean change scores of patients that showed a relevant improvement. Bland and Altman methods were used to quantify the limits of agreement. RESULTS: Area under the ROC curve for the SCORAD was 0.70 [95% confidence interval (CI): 0.61-0.78], for the objective SCORAD, 0.73 (95% CI: 0.70-0.77), for the EASI, 0.67 (95% CI: 0.60-0.76), and for the POEM, 0.67 (95% CI: 0.59-0.75). Scores above 0.70 represent a fair responsiveness. The MCID was 8.7 points for the SCORAD, 8.2 for the objective SCORAD, 6.6 for the EASI, and 3.4 for the POEM. CONCLUSION: The objective SCORAD and SCORAD showed a fair responsiveness. The MCIDs are an important prerequisite for the interpretation of published eczema trials and for the planning/sample size estimation of future trials.


Subject(s)
Dermatitis, Atopic/drug therapy , Immunosuppressive Agents/therapeutic use , Reproducibility of Results , Treatment Outcome , Adult , Area Under Curve , Female , Humans , Male , ROC Curve , Randomized Controlled Trials as Topic
17.
J Eur Acad Dermatol Venereol ; 26(6): 690-5, 2012 Jun.
Article in English | MEDLINE | ID: mdl-21711467

ABSTRACT

Background Ultraviolet radiation following punch grafting may stimulate the migration of melanocytes from the grafts into the vitiliginous skin, thereby increasing the rate of repigmentation. We compared the effects of the 308-nm xenon chloride excimer laser (EL) vs. narrow-band ultraviolet B (NB-UVB) after punch grafting in patients with vitiligo. Objectives The aims of this study were to evaluate (i) repigmentation (%); (ii) treatment satisfaction; and (iii) patient preferences for EL vs. NB-UVB therapy after punch grafting in vitiligo. Methods Fourteen patients were treated with the punch-grafting technique on two symmetrical vitiligo patches. Starting 1 week after the punch grafting, the vitiligo patches were treated twice a week during 3 months, with EL on one side and with NB-UVB on the other side. Repigmentation (%) was measured by a digital image analysis system. Patients' satisfaction and preference for treatment were also assessed. Results Whereas both treatment modalities induced repigmentation, no statistically significant difference was found in grade of repigmentation after 3 months. With EL, 71.4% lower cumulative dose was reached. Patients were significantly more satisfied with NB-UVB and preferred it over EL. Conclusions The choice between EL and NB-UVB cannot solely be based on repigmentation, but rather on other factors, such as patients' preferences. However, given the lower UV dose of EL, we recommend its use in vulnerable populations, such as in small children and patients with sun-damaged skin with a history of long-term UVB treatment.


Subject(s)
Laser Therapy/methods , Lasers, Excimer , Phototherapy , Skin Transplantation , Ultraviolet Rays , Vitiligo/therapy , Adult , Combined Modality Therapy , Female , Humans , Male , Middle Aged , Patient Satisfaction , Single-Blind Method , Vitiligo/surgery
18.
Br J Dermatol ; 162(5): 964-73, 2010 May.
Article in English | MEDLINE | ID: mdl-20331459

ABSTRACT

BACKGROUND: Eczema affects approximately 10% of all schoolchildren in the western world and has shown an increase over the past decades in 'developing' countries. Numerous factors have been suggested that might contribute to the increasing prevalence of eczema. A plausible explanation is the role of environmental factors. As part of the 'hygiene hypothesis' it has been thought that eczema is more common in urban than in rural communities, but such a notion has never been assessed systematically. OBJECTIVE: Our aim was to assess whether there is a rural/urban gradient for the prevalence of eczema and, if so, to what extent. METHODS: All data sources were identified through a search in MEDLINE and EMBASE. All primary studies comparing the prevalence rate of eczema between urban and rural populations were assessed for eligibility. Included articles were reviewed for methodological quality and a relative risk was calculated to indicate the risk of eczema in urban over rural areas. Results Twenty-six articles were included for analysis. Nineteen showed a higher risk for eczema in an urbanized area, of which 11 were significant. Six studies showed a lower risk of eczema in an urbanized area, of which one was statistically significant. One study had a relative risk of 1.00. RESULTS: were more homogeneous among studies of good methodological quality. A pooled relative risk could have been calculated but was not because of heterogeneity. CONCLUSION: There is some evidence of a higher risk for eczema in urban compared with rural areas, suggesting that place of residence may have a role in the pathogenesis of eczema. Future reviews on environmental circumstances should be carried out to reveal the factors associated with a higher prevalence of eczema in urban areas and the association with other allergic diseases.


Subject(s)
Eczema/epidemiology , Rural Health/statistics & numerical data , Urban Health/statistics & numerical data , Adolescent , Child , Child, Preschool , Humans , Infant , Infant, Newborn , Prevalence , Residence Characteristics , Risk Assessment/methods , Young Adult
19.
Br J Dermatol ; 158(4): 754-65, 2008 Apr.
Article in English | MEDLINE | ID: mdl-18241277

ABSTRACT

BACKGROUND: Atopic dermatitis (AD) has a wide spectrum of dermatological manifestations and despite various validated sets of diagnostic criteria that have been developed over the past decades, there is disagreement about its definition. Nevertheless, clinical studies require valid diagnostic criteria for reliable and reproducible results. OBJECTIVE: To summarize the evidence concerning the validity of diagnostic criteria for AD. METHODS: All data sources were identified through searches on Medline, Embase and Cochrane databases. The Quality Assessment of Diagnostic Accuracy tool (QUADAS) was used. Results are presented in a receiver operating characteristic (ROC) plot. RESULTS: Out of the 20 articles that met the criteria, 27 validation studies were identified. In two studies concerning Hanifin and Rajka diagnostic criteria sensitivity and specificity ranged from 87.9% to 96.0% and from 77.6% to 93.8%, respectively. Nineteen validation studies of the U.K. diagnostic criteria showed sensitivity and specificity ranging from 10% to 100% and 89.3% to 99.1%, respectively. Three validation studies concerning the Schultz-Larsen criteria showed sensitivity from 88% to 94.4% and specificity from 77.6% to 95.9%. In one article concerning the criteria of Diepgen, the sensitivity ranged from 83.0% to 87.7% and the specificity from 83.9% to 87.0%. One article studied the Kang and Tian criteria and reported 95.5% sensitivity and 100% specificity. One article validating the International Study of Asthma and Allergies in Childhood (ISAAC) criteria showed a positive and negative predictive value of 48.8% and 91.1%, respectively. CONCLUSION: With this systematic review of the existing sets of diagnostic criteria for AD a varying number of validation studies with varying methodological quality was found. The U.K. diagnostic criteria are the most extensively validated. However, improvement of methodological design for validation studies and uniformity in well-validated and applicable diagnostic criteria are needed to improve future intervention studies and to compare study results.


Subject(s)
Dermatitis, Atopic/diagnosis , Diagnostic Tests, Routine/standards , Dermatitis, Atopic/classification , Humans , International Classification of Diseases , Reference Standards
20.
J Clin Epidemiol ; 60(7): 696-703, 2007 Jul.
Article in English | MEDLINE | ID: mdl-17573985

ABSTRACT

OBJECTIVE: The importance of validly identifying and incorporating patients' views for improving health care is generally acknowledged. Common approaches to assess patients' preferences are based on the quality adjusted life year (QALY) framework, but this ignores a number of aspects that may be relevant. As an alternative, we assessed patients' treatment preferences and trade-offs for five common systemic therapies for psoriasis. STUDY DESIGN AND SETTING: Twenty-nine patients with moderate-to-severe psoriasis expressed treatment preferences for five oral and phototherapies and indicated the relative importance of various treatment attributes, such as adverse effects, discomforts, and safety measures. In a structured interview, they were presented with clinical scenarios that contained descriptions of process and outcome characteristics and illustrations of the anticipated treatment benefit. RESULTS: Over all paired comparisons, methotrexate (33%), cyclosporin (30%), acitretin (15%), UV-B (14%), and PUVA (8%) were preferred to the other treatment. Patients were willing to trade-off their initial preference for more improvement of psoriasis. CONCLUSIONS: Psoriasis patients generally prefer oral to phototherapies and consider most adverse effects and several discomforts important for selecting treatment. Our scenario-based structured interview approach to treatment preferences allowed us to incorporate a broad spectrum of potentially relevant decision components in a clinically meaningful way.


Subject(s)
Patient Satisfaction , Psoriasis/drug therapy , Acitretin/administration & dosage , Acitretin/adverse effects , Administration, Oral , Adult , Cyclosporine/administration & dosage , Cyclosporine/adverse effects , Dermatologic Agents/administration & dosage , Dermatologic Agents/adverse effects , Female , Humans , Keratolytic Agents/administration & dosage , Keratolytic Agents/adverse effects , Male , Methotrexate/administration & dosage , Methotrexate/adverse effects , PUVA Therapy/adverse effects , PUVA Therapy/methods , Psoriasis/psychology , Psoriasis/radiotherapy , Surveys and Questionnaires , Treatment Outcome , Ultraviolet Therapy/adverse effects , Ultraviolet Therapy/methods
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